Clinical Trial SoftwareClinical Trial SoftwareJohn PerryJohn Perry

MIRC Overview – Teaching FilesMIRC Overview – Teaching Files RSNA Clinical Trial and Research SoftwareRSNA Clinical Trial and Research Software Hands On: Using the RSNA Teaching FileHands On: Using the RSNA Teaching File

RSNA 2011 MIRC CoursesRSNA 2011 MIRC CoursesRSNA 2011 MIRC CoursesRSNA 2011 MIRC Courses

Clinical Trial DataflowClinical Trial DataflowClinical Trial DataflowClinical Trial Dataflow

DICOM

DICOM

DICOM

Database

HTTP

InternetHTTP / HTTPS

Data AcquisitionSites

Principal InvestigatorSite

X

X

X

Stand-alone application for clinical trials data:Stand-alone application for clinical trials data: Processing and communicationProcessing and communication

Simple installation and configuration:Simple installation and configuration: Single-click installationSingle-click installation Single XML configuration fileSingle XML configuration file

Configurable for:Configurable for: Data acquisition sitesData acquisition sites Principal investigator sitesPrincipal investigator sites

Platform-independentPlatform-independent

CTPCTPCTPCTP

Administrative functionsAdministrative functions Account managementAccount management Status displayStatus display Configuration displayConfiguration display System properties displaySystem properties display Script editorsScript editors AuthenticationAuthentication

CTP Admin Web ServerCTP Admin Web ServerCTP Admin Web ServerCTP Admin Web Server

DicomObjectDicomObjectImagesImagesSR / KOS / GSPS objectsSR / KOS / GSPS objects

XmlObjectXmlObjectText dataText dataFlexible schema for identifiersFlexible schema for identifiers

ZipObjectZipObjectEncapsulation of trial-specific filesEncapsulation of trial-specific filesEmbedded manifest to carry the identifiersEmbedded manifest to carry the identifiers

CTP Data ObjectsCTP Data ObjectsCTP Data ObjectsCTP Data Objects

A pipeline is an ordered sequence of stagesA pipeline is an ordered sequence of stages A stage is an element to perform a function:A stage is an element to perform a function:

ImportServiceImportService ProcessorProcessor StorageServiceStorageService ExportServiceExportService

Pipelines can have as many stages as necessaryPipelines can have as many stages as necessary CTP supports multiple pipelinesCTP supports multiple pipelines

CTP Processing PipelinesCTP Processing PipelinesCTP Processing PipelinesCTP Processing Pipelines

DicomImportServiceDicomImportService - DICOM Storage SCP- DICOM Storage SCP

HttpImportServiceHttpImportService - HTTP and HTTPS- HTTP and HTTPS

PollingHttpImportServicePollingHttpImportService - HTTP for firewall penetration- HTTP for firewall penetration

DirectoryImportServiceDirectoryImportService - manual submission- manual submission

ArchiveImportServiceArchiveImportService - bulk import- bulk import

Standard ImportServicesStandard ImportServicesStandard ImportServicesStandard ImportServices

DicomFilterDicomFilter - - triage for DicomObjectstriage for DicomObjectsXmlFilterXmlFilter - - triage for XmlObjectstriage for XmlObjectsZipFilterZipFilter - - triage for ZipObjectstriage for ZipObjectsDicomAnonymizerDicomAnonymizer - - de-identify DicomObjectsde-identify DicomObjectsXmlAnonymizerXmlAnonymizer - de-identify XmlObjects- de-identify XmlObjectsZipAnonymizerZipAnonymizer - de-identify ZipObject manifests- de-identify ZipObject manifests

Standard ProcessorsStandard ProcessorsStandard ProcessorsStandard Processors

DicomDecompressorDicomDecompressor - - convert DICOM imagesconvert DICOM imagesDicomTranscoderDicomTranscoder - - convert DICOM imagesconvert DICOM imagesDicomPixelAnonymizerDicomPixelAnonymizer - - blank pixel regionsblank pixel regions

Standard ProcessorsStandard ProcessorsStandard ProcessorsStandard Processors

ObjectLoggerObjectLogger - performance measurement- performance measurementObjectCacheObjectCache - 21CFR11-compliant trials- 21CFR11-compliant trialsMemoryMonitorMemoryMonitor - operation monitoring- operation monitoring IDMapIDMap - PHI ID lookup- PHI ID lookupObjectTrackerObjectTracker - data acquisition management- data acquisition managementDatabaseVerifierDatabaseVerifier - transfer confirmation between sites- transfer confirmation between sites

Standard ProcessorsStandard ProcessorsStandard ProcessorsStandard Processors

FileStorageServiceFileStorageServiceIndexed file managementIndexed file managementWeb access with authenticationWeb access with authentication

BasicFileStorageServiceBasicFileStorageServiceIndexed file management for the National Cancer Indexed file management for the National Cancer

Institute NBIA systemInstitute NBIA systemDirectoryStorageServiceDirectoryStorageService

File management for the RSNA Image Sharing ProjectFile management for the RSNA Image Sharing Project

Standard StorageServicesStandard StorageServicesStandard StorageServicesStandard StorageServices

DicomExportServiceDicomExportService - DICOM Storage SCU- DICOM Storage SCUHttpExportServiceHttpExportService - HTTP and HTTPS- HTTP and HTTPSPolledHttpExportService PolledHttpExportService - HTTP for firewall penetration- HTTP for firewall penetrationFtpExportServiceFtpExportService - FTP- FTPDatabaseExportService DatabaseExportService - external database interface- external database interfaceAimExportService AimExportService - interface to AIM repositories- interface to AIM repositories

Standard ExportServicesStandard ExportServicesStandard ExportServicesStandard ExportServices

Configurable tree structureConfigurable tree structure Build-in web serverBuild-in web server

AuthenticationAuthentication Browse patients / studies / data objectsBrowse patients / studies / data objects Display images (tile / stack / series)Display images (tile / stack / series) Export data objects of all typesExport data objects of all types Programmatic access via Ajax servletProgrammatic access via Ajax servlet

FileStorageServiceFileStorageServiceFileStorageServiceFileStorageService

FileStorageService ViewerFileStorageService ViewerFileStorageService ViewerFileStorageService Viewer

Integrated queue managementIntegrated queue management DatabaseAdapterDatabaseAdapter

Interface between the DatabaseExportService and the Interface between the DatabaseExportService and the database itselfdatabase itself

Must be developed for each unique database schemaMust be developed for each unique database schema Standard class to extend for a specific applicationStandard class to extend for a specific application

DatabaseExportServiceDatabaseExportServiceDatabaseExportServiceDatabaseExportService

AuditLogAuditLog - 21CFR11-compliant trials- 21CFR11-compliant trials

MIRCMIRC - teaching files- teaching files

Standard PluginsStandard PluginsStandard PluginsStandard Plugins

Plugins add functionality beyond the scope of Plugins add functionality beyond the scope of a single pipeline stagea single pipeline stage

1.1. Name Name 2.2. Location; all geographic subdivisions smaller than a Location; all geographic subdivisions smaller than a

state, including street address, city, county, precinct, state, including street address, city, county, precinct, zip code, and their equivalent geocodes. zip code, and their equivalent geocodes.

3.3. Dates (all dates related to the subject of the Dates (all dates related to the subject of the information, e.g. birth dates, admission dates, information, e.g. birth dates, admission dates, discharge dates, encounter dates, surgery dates, etc.) discharge dates, encounter dates, surgery dates, etc.)

The HIPAA 18 The HIPAA 18 (1-3)(1-3)The HIPAA 18 The HIPAA 18 (1-3)(1-3)

4.4. Telephone numbers Telephone numbers 5.5. Fax numbers Fax numbers 6.6. Electronic mail addresses Electronic mail addresses 7.7. Social security numbers Social security numbers 8.8. Medical record numbers Medical record numbers 9.9. Health plan beneficiary numbersHealth plan beneficiary numbers

The HIPAA 18 The HIPAA 18 (4-9)(4-9)The HIPAA 18 The HIPAA 18 (4-9)(4-9)

10.10. Account numbers Account numbers 11.11. Certificate / license numbers Certificate / license numbers 12.12. Vehicle identifiers and serial numbers, Vehicle identifiers and serial numbers,

including license plate numbers including license plate numbers 13.13. Device identifiers and serial numbers Device identifiers and serial numbers 14.14. Web Uniform Resource Locators (URLs)Web Uniform Resource Locators (URLs)15.15. Internet Protocol (IP) address numbers Internet Protocol (IP) address numbers

The HIPAA 18 The HIPAA 18 (10-15)(10-15)The HIPAA 18 The HIPAA 18 (10-15)(10-15)

16.16. Biometric identifiers, including finger and voice Biometric identifiers, including finger and voice prints prints

17.17. Full face photographic images and any Full face photographic images and any comparable images comparable images

18.18. Any other unique identifying number, Any other unique identifying number, characteristic, or code characteristic, or code

The HIPAA 18 The HIPAA 18 (16-18)(16-18)The HIPAA 18 The HIPAA 18 (16-18)(16-18)

Unnecessary PHIUnnecessary PHI RemovalRemoval Replacement with values that are the same for all Replacement with values that are the same for all

patientspatients Necessary PHINecessary PHI

Replacement with values that allow subjects, studies, Replacement with values that allow subjects, studies, and images to be related to one-another, but that do and images to be related to one-another, but that do not allow identification of the human beingnot allow identification of the human being

De-indentificationDe-indentificationDe-indentificationDe-indentification

Published in 2009Published in 2009 Defines de-identification profilesDefines de-identification profiles Basic Profile: most aggressiveBasic Profile: most aggressive Several options for relaxing certain IDsSeveral options for relaxing certain IDs This is a This is a majormajor contribution: it provides expert contribution: it provides expert

guidance for the de-identification of complex guidance for the de-identification of complex datasetsdatasets

DICOM Supplement 142DICOM Supplement 142DICOM Supplement 142DICOM Supplement 142

Fully scriptable de-identification instructionsFully scriptable de-identification instructions DICOM Anonymizer ConfiguratorDICOM Anonymizer Configurator

Web UI for creating and editing scriptsWeb UI for creating and editing scripts Support for DICOM Supplement 142 profilesSupport for DICOM Supplement 142 profiles

Profile scripts written by Justin Kirby at NCIProfile scripts written by Justin Kirby at NCI Support for user-defined profilesSupport for user-defined profiles

Default script: 142 BasicDefault script: 142 Basic

CTP DicomAnonymizerCTP DicomAnonymizerCTP DicomAnonymizerCTP DicomAnonymizer

CTP ExampleCTP ExampleCTP ExampleCTP Example

CTP

DicomImportServiceDicomAnonymizerHttpExportService

Data Acquisition Site

CTP

HttpImportServiceFileStorageServiceDatabaseExportServiceDicomExportService

Principal Investigator Site

…Modality

PACS

External DatabaseWorkstation

Local Disk

Firewall PenetrationFirewall PenetrationFirewall PenetrationFirewall Penetration

DMZ

CTPPollingHttpImportService… (additional stages)

Secure Network

CTPHttpImportServicePolledHttpExportService

DMZ

InternetHTTP / HTTPS

Principal Investigator Site

Flexible Flexible All standard stages are highly configurableAll standard stages are highly configurable

ExtensibleExtensible Interface-based structureInterface-based structure Abstract classes for easy development of new stagesAbstract classes for easy development of new stages Base class for developing database interfacesBase class for developing database interfaces

Adapting CTPAdapting CTPAdapting CTPAdapting CTP

Runs on Windows, Mac, Linux, SolarisRuns on Windows, Mac, Linux, SolarisRequires only JavaRequires only Java Java and CTP are freeJava and CTP are freeMIRC/CTP Users Meeting:MIRC/CTP Users Meeting:

Monday, 11/28, from 3:00-4:15 in N128Monday, 11/28, from 3:00-4:15 in N128

CTPCTPCTPCTP

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